Clinical trial · Interventional
Single Agent Abraxane as Second Line Therapy in Bladder Cancer
A Multi-Institutional Phase II Study of Single Agent Abraxane as Second Line Therapy in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
NCT00683059CI-TRIAL-00024310completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine what effects the drug Abraxane has on bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nab-paclitaxel
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- one year
Secondary outcomes (2)
- measure
- safety
- timeFrame
- 1 year
- measure
- overall survival
- timeFrame
- 1-2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histological or cytological diagnosis of urothelial carcinoma. Mixed histologies are permitted as long as transitional cell carcinoma is the major component (i.e. \>50% of the pathologic specimen). Pure or predominant squamous cell carcinomas are not permitted. * Patients with transitional cell carcinomas of the renal pelvis and ureter are permitted. * Patients must have metastatic or locally advanced unresectable disease. * Patients must have received one and only one prior chemotherapeutic regimen which included a platinum (at least one cycle) for metastatic/recurrent disease. Neoadjuvant or adjuvant chemotherapy will be considered to have been first line if the patient progressed within 12 months of the last dose. * Neoadjuvant/adjuvant chemotherapy (with or without a taxane) is permitted if registration is greater than 12 months since the last dose (patients must then have received one platinum containing regimen in the metastatic setting) * ECOG performance status \<= 2. * Estimated life expectancy of \>12 weeks. * Patients must have measurable disease according to RECIST criteria. * If female of childbearing potential, pregnancy test is negative within 72 hours priors to first dose of study drug. * If fertile, patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study. * Adequate organ function; Absolute neutrophil count \>1.5 x 109/L. Platelet count \>100 x109/L. Hemoglobin \>90 g/L. Total bilirubin \<1.5x upper limit of normal. Transaminases \<3x upper limit of normal (\<5x if liver metastasis are present) Calculated creatinine clearance \>40 ml/min (Cockcroft \& Gault formula) * Able to give informed consent. Exclusion Criteria: * Prior taxane therapy for metastatic disease (or \> 12 months since a taxane-containing neoadjuvant or adjuvant chemotherapy). * Pre-existing peripheral neuropathy \>1 by NCI-CTC criteria. * Pregnant or lactating females. * Uncontrolled brain or leptomeningeal involvement (treated brain metastasis permitted if both known lesions and medications e.g. steroids for that indication are stable). * History of serious or concurrent illness that might be aggravated by study treatment. * History of class II-IV congestive heart failure. * Other malignancies except adequately controlled basal cell carcinoma of the skin or carcinoma in situ of the cervix or incidental prostate cancer (T1a, Gleason \<7 PSA \<10ng/ml) or any other tumor within 5 years prior to enrollment. * Other investigational therapy or radiation therapy within 30 days before registration. * Patients not willing to employ adequate contraception for the duration of the study.
References
Publications (1)
- DERIVEDKo YJ, Canil CM, Mukherjee SD, Winquist E, Elser C, Eisen A, Reaume MN, Zhang L, Sridhar SS. Nanoparticle albumin-bound paclitaxel for second-line treatment of metastatic urothelial carcinoma: a single group, multicentre, phase 2 study. Lancet Oncol. 2013 Jul;14(8):769-76. doi: 10.1016/S1470-2045(13)70162-1. Epub 2013 May 22. PMID 23706985